Regulation (EC) No 470/2009 Article 4

Opinion of the Agency

Article 4

1. The opinion of the Agency shall consist of a scientific risk assessment and risk management recommendations. 2. The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products. The opinion shall take account of any relevant scientific findings of the European Food Safety Authority (EFSA) established by Article 22 of Regulation (EC) No 178/2002.

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Other provisions in Section 1 — Pharmacologically active substances intended for use in veterinary medicinal products in the Community

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 4 of Regulation (EC) No 470/2009 (LawPlayer, data as of 2026-07-04)

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